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C17H21NO4 303.35

8-Azabicyclo[3.2.1]octane-2-carboxylic acid,3-(benzoyloxy)-8-methyl-,methyl ester,[1R-(exo,exo)]-.

Methyl 3b-hydroxy-1aH,5aH-tropane-2b-carboxylate benzoate (ester) [50-36-2].
»Cocaine,dried over phosphorus pentoxide for 3hours,contains not less than 99.0percent and not more than 101.0percent of C17H21NO4.
Packaging and storage— Preserve in well-closed,light-resistant containers.
A: Ultraviolet Absorption á197Uñ
Solution: 15µg per mL.
Medium: dilute hydrochloric acid (1in 120).
Absorptivities at 233nm,calculated on the dried basis,do not differ by more than 3.0%.
B: It meets the requirements under Identification—Organic Nitrogenous Bases á181ñ,USP Cocaine Hydrochloride RSbeing used,and sodium carbonate TSbeing used in place of sodium hydroxide TS.
C: Dissolve about 100mg in a mixture of 0.4mLof dilute hydrochloric acid (1in 12)and water to make 5mL,and add 5drops of chromium trioxide solution (1in 20):a yellow precipitate is formed,and it quickly redissolves when the mixture is shaken.Add 1mLof hydrochloric acid:a permanent,orange-colored,crystalline precipitate is formed.
D: Dissolve about 10mg in 1mLof dilute hydrochloric acid (1in 600),and evaporate on a steam bath just to dryness.Dissolve the residue in 2drops of water,and add 1mLof potassium permanganate solution (1in 300):a violet,crystalline precipitate is formed,and it appears brownish violet when collected on a filter,and shows characteristic violet-red crystalline aggregates under the low power of a microscope,similar to those obtained from USP Cocaine Hydrochloride RS.
Melting range,Class Iá741ñ: between 96and 98.
Loss on drying á731ñ Dry it over phosphorus pentoxide for 3hours:it loses not more than 1.0%of its weight.
Residue on ignition á281ñ: not more than 0.1%.
Readily carbonizable substances á271ñ Dissolve about 500mg in 5mLof sulfuric acid TS:the solution has no more color than Matching Fluid A.
Limit of cinnamyl-cocaine and other reducing substances— Dissolve about 300mg of finely powdered Cocaine in 1mLof dilute hydrochloric acid (1in 12)with the aid of heat,if necessary,and dilute with water to 15mL.Mix 5mLof this solution with 0.3mLof dilute sulfuric acid (1in 35)and 0.1mLof potassium permanganate solution (1in 300):the violet color does not disappear entirely within 30minutes.
Limit of isoatropyl-cocaine— Dilute in a beaker 5mLof the solution of Cocaine prepared in the test for Cinnamyl-cocaine and other reducing substanceswith 80mLof water,add 0.2mLof 6Nammonium hydroxide,and stir the solution vigorously for 5minutes,occasionally rubbing the inner wall of the beaker with a stirring rod:a crystalline precipitate of cocaine is formed,and the supernatant is clear.
Assay— Dissolve about 600mg of Cocaine,previously dried and accurately weighed,in 50mLof glacial acetic acid,add 1drop of crystal violet TS,and titrate with 0.1Nperchloric acid VSto a green endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 30.34mg of C17H21NO4.
Auxiliary Information— Staff Liaison:Gabriel I.Giancaspro,Ph.D.,Senior Scientist and Latin American Specialist
Expert Committee:(DSB)Dietary Supplements:Botanicals
USP28–NF23Page 530
Phone Number:1-301-816-8343